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Abstract Details

Activity Number: 161
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305242
Title: Graphical Procedures for Multiple Testing in Families of Primary and Secondary Hypotheses
Author(s): Ekkehard Glimm*+
Companies: Novartis
Address: , , ,
Keywords: multiple comparisons ; graphical methods ; clinical trials
Abstract:

In clinical trials, the effect of a new treatment is often investigated in multiple endpoints, for example different patient characteristics (e.g. weight loss and change of HBA1C level), different doses of a drug, different time points at which the effect is measured, or combinations thereof. When the new treatment is compared to an established standard-of-care or placebo, control of the familywise error rate is often required to avoid over-optimistic conclusions about the effect of the new treatment. In addition, some of the comparisons are more important than others, such that partial hierarchies of primary and secondary hypotheses arise. Such structures - which are more complex than situations where hypotheses are all equally important or can be arranged in a strict hierarchy - are not easily handled with traditional multiplicity adjustment methods. Bretz et al. (2009, Statistics in Medicine 28, 586-604) have suggested a class of stepwise methods for this which can be elegantly represented by graphs. The talk will present the approach by Bretz et al. (2009) and discuss various examples of their implementation and some extensions to the situation of correlated data.


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